Rituximab With or Without Lenalidomide in Treating Patients With Previously Untreated Follicular Lymphoma

DISEASE CHARACTERISTICS:

• Histologically confirmed follicular lymphoma

  • Stage III or IV disease OR stage II disease not suitable for radiotherapy
  • Grades 1, 2, or 3a disease
• Previously untreated disease
• CD20-positive disease

• Patients in need of systemic therapy, meeting at least 1 of the following criteria:

  • Symptomatic enlarged lymph nodes, spleen, or other lymphoma manifestations
  • Bulky disease ≥ 6 cm in long diameter
  • Clinically significant progression over at least 6 months of any tumor lesion
  • Anemia (hemoglobin < 100 g/L) or thrombocytopenia (platelet count < 100 x 10^9/L) due to lymphoma
  • Clinically significant progressive decrease in hemoglobin or platelet count due to lymphoma
  • B-symptoms, weight loss > 10% within the past 6 months, drenching night sweats, or fever > 38°C not due to infection
• At least one two-dimensionally measurable lesion with longest transverse diameter > 10 mm
• Paraffin-embedded tumor tissue available
• No known CNS involvement

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• EF ≥ 50% for patients with a history of cardiac disease or older than 70 years
• Neutrophil count ≥ 1.5 x 10^9/L
• Platelet count ≥ 100 x 10^9/L
• Bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless due to Gilbert syndrome)
• ALT ≤ 2.5 x ULN
• Alkaline phosphatase ≤ 2.5 x ULN
• Creatinine clearance ≥ 30 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception 4 weeks prior to, during, and for 12 months after completion of study therapy
• Must be compliant and geographically proximal to allow for proper staging and follow-up
• No serious underlying medical condition, at the judgment of the investigator, which could impair the ability of the patient to participate in the trial (e.g., active autoimmune disease or uncontrolled diabetes)
• No malignancy within the past 3 years except for adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer
• No psychiatric disorder precluding understanding information of trial-related topics, giving informed consent, or interfering with compliance for oral drug intake
• No known hypersensitivity to trial drugs or hypersensitivity to any other components of the trial drugs
• No known HIV positivity or hepatitis C infection
• No serological evidence of current or past hepatitis B infection, unless the serological findings are clearly due to vaccination

PRIOR CONCURRENT THERAPY:

• No prior systemic therapy for this disease
• At least 3 months since prior radiotherapy
• At least 30 days since prior treatment in another clinical trial
• At least 4 weeks since prior and no concurrent corticosteroids unless administered as prophylaxis in at-risk patients for ≤ 3 days or at a dose equivalent to prednisone ≤ 15 mg/day, for indications other than lymphoma or lymphoma-related symptoms
• No concomitant drugs contraindicated for use with the trial drugs
• No other concurrent experimental drugs or anticancer therapy
• No other concurrent investigational treatments